Risk Management ISO 14971

In ISO 13485 top management is charged with the management of device-related risks and the development of risk management plans, ISO 14971 defines steps to be taken by a risk team in order to fulfill risk-related requirements. It is not mandatory that a manufacturer be ISO 14971 certified in order to attain ISO 13485 certification. But ISO 13485 must be included in the QMS processes.

The fact that ISO 13485 notes the application of ISO 14971 recognizes its importance for those seeking ISO 13485 certification. Compliance programs for both standards, when implemented together, can help manufacturers build an enterprise program for risk management and quality assurance. Evidencing the consistent assessment and mitigation of risks throughout all stages of a products lifecycle is important for achieving certification to ISO 13485 and controlling post-marketing costs .